Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tolcapone
Drug ID BADD_D02241
Description Tolcapone is a drug that inhibits the enzyme catechol-O-methyl transferase (COMT). It is used in the treatment of Parkinson's disease as an adjunct to levodopa/carbidopa medication. It is a yellow, odorless, non-hygroscopic, crystalline compound. Tolcapone is associated with a risk of hepatotoxicity.
Indications and Usage Used as an adjunct to levodopa/carbidopa therapy for the symptomatic treatment of Parkinson's Disease. This drug is generally reserved for patients with parkinsonian syndrome receiving levodopa/carbidopa who are experiencing symptom fluctuations and are not responding adequately to or are not candidates for other adjunctive therapies.
Marketing Status approved; withdrawn
ATC Code N04BX01
DrugBank ID DB00323
KEGG ID D00786
MeSH ID D000077867
PubChem ID 4659569
TTD Drug ID D0Y7PG
NDC Product Code 50742-193; 0187-0938; 68682-938; 17511-119; 65085-0032; 76438-001
UNII CIF6334OLY
Synonyms Tolcapone | 3,4-Dihydroxy-5'-methyl-5-nitrobenzophenone | 3,4 Dihydroxy 5' methyl 5 nitrobenzophenone | SOM0226 | Ro 40-7592 | Ro 40 7592 | Ro 407592 | Ro-40-7592 | Ro407592 | Tasmar
Chemical Information
Molecular Formula C14H11NO5
CAS Registry Number 134308-13-7
SMILES CC1=CC=C(C=C1)C(=O)C2=CC(=C(C(=C2)O)O)[N+](=O)[O-]
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Depression19.15.01.001--
Dermatitis23.03.04.002---
Diabetes mellitus05.06.01.001; 14.06.01.001---
Diarrhoea07.02.01.001--
Diplopia06.02.06.002; 17.17.01.005---
Discomfort08.01.08.003---
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dry mouth07.06.01.002--
Duodenal ulcer07.04.02.002--
Dysgeusia07.14.03.001; 17.02.07.003--
Dyskinesia17.01.02.006--
Dyspepsia07.01.02.001--
Dysphagia07.01.06.003--
Dyspnoea02.11.05.003; 22.02.01.004--
Dystonia17.01.03.001---
Dysuria20.02.02.002--
Ear pain04.03.01.003--
Eczema23.03.04.006--
Encephalopathy17.13.02.001--
Endophthalmitis06.04.05.009; 11.01.06.003--
Epistaxis22.04.03.001; 24.07.01.005--
Erythema multiforme10.01.03.015; 23.03.01.003--
Euphoric mood19.04.02.006--
Extrapyramidal disorder17.01.02.007--
Eye haemorrhage06.07.02.001; 12.02.02.012; 24.07.05.002---
Eye inflammation06.04.05.002---
Eye pain06.08.03.002--
Face oedema08.01.07.003; 10.01.05.002; 23.04.01.004--
Fall12.01.08.002--
Fatigue08.01.01.002--
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